TrialSignal
Clinical trial intelligence report
A Two-Stage Phase III, International, Multi-Center, Randomized, Controlled, Open-Label Study to Investigate the Pharmacokinetics, Efficacy and Safety of Rituximab SC in Combination With CHOP or CVP Versus Rituximab IV in Combination With CHOP or CVP in Patients With Previously Untreated Follicular Lymphoma Followed by Maintenance Treatment With Either Rituximab SC or Rituximab IV
Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.
Generated
Jun 13, 2026
NCT ID
NCT01200758
Status
COMPLETED
Phase
PHASE3
Sponsor
Hoffmann-La Roche
Executive brief
Investment-Ready Snapshot
This two-stage, multi-center, randomized, controlled, open-label study will investigate the pharmacokinetics, efficacy and safety of rituximab SC versus rituximab IV in participants with previously untreated follicular non-Hodgkin's lymphoma. Participants will be randomized to receive 375 milligrams per meter square (mg/m\^2) rituximab as IV infusion or 1400 milligrams (mg) rituximab SC. In addition, participants will receive standard chemotherapy. Participants who achieved a complete or partial response (PR) after 8 treatment cycles, will receive maintenance treatment for a further maximum number of 12 cycles. Maintenance treatment cycles will be repeated every 8 weeks. This is a two-stage study. Stage 1 was designed to confirm the chosen rituximab SC dose resulting in comparable rituximab serum Ctrough levels compared with rituximab IV, when given as part of induction treatment every 3 weeks. Enrollment for Stage 2 started after the rituximab SC dose was established in Stage 1. Stage 2 aimed to further investigate the efficacy and safety of rituximab SC compared with rituximab IV. The anticipated time on study treatment is 96 weeks.
Source & freshness
Provenance
https://clinicaltrials.gov/study/NCT01200758
Indication
Non-Hodgkin's Lymphoma
Modality
monoclonal antibody
Target
Rituximab SC, Rituximab IV, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone/Prednisolone
Intervention
Rituximab SC, Rituximab IV, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone/Prednisolone
Source record
Protocol Description
Detailed source ingestion pending.
Source record
Outcome Measures
Detailed source ingestion pending.
Source record
Eligibility
Detailed source ingestion pending.
AI analysis
Known Results And Readout Context
Detailed source ingestion pending.
IP intelligence
Patent And IP Landscape
Detailed source ingestion pending.
Source record
Contacts
Detailed source ingestion pending.